FDA clears tiratricol for MCT8 deficiency, lowering dangerous T3 and outlining dosing, lab testing, and pharmacy access.
|Articles|October 8, 2021
Daily Medication Pearl: Cemiplimab (Libtayo)
Author(s)Saro Arakelians, PharmD
Cemiplimab is a recombinant human immunoglobulin G4 monoclonal antibody that binds to PD-1 and blocks its interaction with PD-L1 and PD-L2.
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Medication Pearl of the Day: Cemiplimab (Libtayo)
Indication: For cutaneous squamous cell carcinoma (CSCC), for the treatment of patients with metastatic cutaneous squamous cell carcinoma or locally advanced CSCC, for basal cell carcinoma, and non-small cell lung cancer.
Insight:
- Dosing: The recommended dosage of cemiplimab is 350 mg as an intravenous infusion over 30 minutes every 3 weeks.
- Dosage form: Injection 350 mg/7 mL (50 mg/mL) solution in a single-dose vial.
- Adverse Events (AEs): The most common AEs (≥15%) are musculoskeletal pain, fatigue, rash, and diarrhea. The most common grade 3-4 laboratory abnormalities (≥2%) were lymphopenia, hyponatremia, hypophosphatemia, increased aspartate aminotransferase, anemia, and hyperkalemia.
- Mechanism of Action: Cemiplimab is a recombinant human immunoglobulin G4 (IgG4) monoclonal antibody that binds to programmed cell death protein 1 (PD-1) and blocks its interaction with programmed death-ligand 1 (PD-L1) and PD-L2, releasing PD-1 pathway-mediated inhibition of the immune response, including the anti-tumor immune response. In syngeneic mouse tumor models, blocking PD-1 activity resulted in decreased tumor growth.
- Manufacturer: Regeneron
Source:
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